|
ISRCTN
|
ISRCTN64336220
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised double-blind placebo-controlled cancer prevention trial with an estimated duration of 5 years and with 52,000 subjects recruited from the general populations of the UK, Denmark, Sweden, Finland and the United States
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
PRECISE
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised double-blind placebo-controlled
|
|
Countries of recruitment
|
Denmark, Finland, Sweden, UK, USA
|
|
Disease/condition/study domain
|
Multiple cancer sites
|
|
Participants - inclusion criteria
|
All those aged between 60 and 74 years are eligible.
|
|
Participants - exclusion criteria
|
1. Southwest Oncology Group (SWOG) performance status score of greater then 1 or equivalent
2. Active liver or kidney disease
3. Prior diagnosis of cancer
4. Diagnosed Human Immunodeficiency Virus (HIV) infection
5. Disminished mental capacity
6. Taking 50 micrograms/day or more of selenium supplements
|
|
Anticipated start date
|
01/01/1995
|
|
Anticipated end date
|
29/06/2001
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
52000
|
|
Interventions
|
Four treatment groups:
1. Placebo
2. 100 micrograms selenium/day
3. 200 micrograms selenium/day
4. 300 micrograms selenium/day
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Cancer Research UK
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
28/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|
